Lifestyle Intervention for Rheumatoid Arthritis

NCT ID: NCT05554705

Last Updated: 2023-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-02

Study Completion Date

2023-01-02

Brief Summary

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The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis.

Detailed Description

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The main purpose of this study is to assess whether adding a multifaceted lifestyle intervention to the standard best practice of care can be more effective than standard best practices alone for treating Rheumatoid Arthritis. If a lifestyle intervention is effective, we expect to see improvement in functional status and decreased health care costs to the study participant and the insurer.

Conditions

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Lifestyle Risk Reduction Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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experimental

standard of care + lifestyle intervention

Group Type EXPERIMENTAL

Intensive Lifestyle intervention

Intervention Type BEHAVIORAL

12 week therapeutic lifestyle change program

control

no intervention (control group)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intensive Lifestyle intervention

12 week therapeutic lifestyle change program

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. BCBSVT members who also carry the prescription benefit with BCBSVT (due to the need for tracking prescription costs).
2. BCBSVT membership for minimum of 12 months prior to start of study (due to the need for tracking prescription costs before and after intervention).
3. Age 18 or older
4. Medical diagnosis of RA

Exclusion Criteria

1. Pregnancy
2. Currently taking warfarin (since fluctuating amounts of green leafy vegetable intake can adversely affect INR levels and because we will be asking participants to increase the amount of green leafy vegetables they consume)
3. Malignancy currently undergoing treatment (with further planned treatment at the time of enrollment) since patients undergoing cancer treatment often need to stop RA medications in order to improve immune function, and thus could be a confounder.
4. Food allergy (including reactions such as hives, wheezing, difficulty breathing, fainting, or anaphylaxis)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Blue Cross Blue Shield of Vermont

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Keri LeCompte, PharmD

Role: PRINCIPAL_INVESTIGATOR

Blue Cross Blue Shield of Vermont

Locations

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Blue Cross Blue Shield of Vermont

Berlin Corners, Vermont, United States

Site Status

Countries

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United States

Other Identifiers

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22-08-629-1275

Identifier Type: -

Identifier Source: org_study_id

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